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Efficiency and Usability of the Iontophoretic Patch Feeligreen Diclofenac in Treating Acute Osteoarthritic Knee Pain

C

Centre Hospitalier Universitaire de Nice

Status

Withdrawn

Conditions

Osteoarthritis

Treatments

Device: Feeligreen patch

Study type

Interventional

Funder types

Other

Identifiers

NCT02784691
15-PP-15

Details and patient eligibility

About

The aim of the study is to evaluate the antalgic efficacity of Feeligreen® patch on osteoarthritic knee pain acute. This patch work by diffusion controlled by iontophoresis allowing an improvement of transdermal diffusion of active (Diclofenac).

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with age above 70 years,
  • Having a knee Arthritis (unilateral or bilateral) for at least 6 months,
  • Pain intensity ≥ 40 mm on a visual analog scale (VAS)
  • Lack of analgesic treatment or analgesic,

Exclusion criteria

  • Cognitive disorders : moderate to severe stage or not allowing an understanding of the VAS (as determined by the clinician)
  • A history of chronic inflammatory rheumatic disease,
  • Diagnosis of osteoarthritis of secondary origin,
  • Non-steroidal anti-inflammatory medication within 7 days prior to inclusion,
  • Diagnosis of severe hepatic and renal insufficiency, gastrointestinal bleeding, severe heart failure,
  • Allergy to diclofenac or similar activity substances such as other NSAIDs, aspirin, excipients,
  • Damaged skin

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Patients
Experimental group
Treatment:
Device: Feeligreen patch

Trial contacts and locations

1

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Central trial contact

Christine PINTARIC

Data sourced from clinicaltrials.gov

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